Body Analysis Scale, Model BG 17

FDA 510(k) K110928 · Shenzhen Healthcare Electronic Technology Co., Ltd.

Substantially Equivalent

510(k) numberK110928

Submission

Device name
Body Analysis Scale, Model BG 17
Applicant
Shenzhen Healthcare Electronic Technology Co., Ltd.
Echo, OR, US
Received
April 4, 2011
Decision date
July 15, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNW – Analyzer, Body Composition
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2770
Specialty
Cardiovascular

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Questions and answers

When was Body Analysis Scale, Model BG 17 cleared by the FDA?

Body Analysis Scale, Model BG 17 (K110928) received a 510(k) decision of Substantially Equivalent on July 15, 2011, 102 days after the submission was received.

What is the product code of K110928?

The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.